Enhanced stability implantable medical device

ABSTRACT

An implantable medical device is provided which has a housing of an elongate form to minimize a size of an incision required for implantation. A stabilizing element is associated with the elongated form housing for the medical device. The stabilizing element transitions from a low profile initial form to a higher width final form to provide the medical device with a stabilized footprint after implantation. The stabilizing element is in the form of a rotating wing in one embodiment. In another embodiment, the stabilizing element is in the form of an expanding loop that can bend to extend out of side openings of a cavity within the housing, to provide such stabilization at the implantation site. The medical device can be in the form of a pacemaker, infusion pump, vascular access port or other subcutaneously implanted medical device.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.12/287,398, filed on Oct. 8, 2008 and issued as U.S. Pat. No. 8,209,015on Jun. 26, 2012, which claims benefit under Title 35, United StatesCode §119(e) of U.S. Provisional Application No. 60/960,640 filed onOct. 9, 2007.

FIELD OF THE INVENTION

The following invention relates to medical devices which are implantedsubcutaneously to provide a therapeutic benefit for a patient at theimplantation site. More particularly, this invention relates tosubcutaneously implanted medical devices which have a low profile formfor minimally invasive implantation through a small incision, but whichcan be adjusted in form to have a highly stable configuration afterimplantation to resist movement after implantation. Such medical devicescould be in the form of pacemakers, infusion devices, such as infusionpumps, vascular access ports, or other medical devices which are taughtin the prior art to be implanted subcutaneously to provide a therapeuticbenefit within a patient.

BACKGROUND OF THE INVENTION

A variety of medical conditions have been identified where implantationof a medical device is indicated. Such medical devices can includepacemakers, infusion pumps, vascular access ports, nerve stimulators,spinal stimulators, etc. Each of these medical devices generally includesome form of housing which at least partially contains portions of themedical device apparatus to isolate this medical device apparatus frombodily fluids or bodily structures outside of the housing. Furthermore,typically some form of interface extends out of the housing to interactwith surrounding bodily systems. For instance, in the case of apacemaker electrodes extend from the housing as electrical leads whichare coupled to nerves of the heart which, when receiving electricalstimulus from the pacemaker, cause the heart to beat. Infusion pumpsinclude an outlet tube passing into a location where the preparationbeing infusion is to be delivered. For instance, if the infusion pump isinfusing a pain medication, it would typically be implanted into avascular structure, such as into a vein of the patient.

With such prior art medical devices, such implantation has required thatthe medical device be configured and positioned in a way that keeps themedical device stationary within the body. Such configuration hasgenerally involved shaping the devices to be generally flat and eithercircular or square/rectangular in form (viewed from above). “TwiddlersSyndrome” refers to a situation where a subcutaneous medical device hasbeen manipulated by the patient (or sometimes spontaneously) and flippedover upon itself one or more times, so that the device function isadversely affected. This can lead to fracture of output devices andpotential failure of the medical device.

The shape of these medical devices requires that a relatively largeincision be made to pass the medical device through the skin duringsurgical implantation of the medical device. As the size of the incisionincreases, the difficulty associated with hiding the incision fromvisual detection by others is increased. Generally, patients appreciatehaving small incisions when medical devices are to be implanted. Withknown prior art technology of the shape described above, such incisionshave not been minimized. To some extent electronics and other componentswithin a housing of the medical device can be miniaturized to minimize asize of the medical device and hence the required incision. However,such miniaturization has limits and other complications are associatedwith such miniaturization including enhanced cost and potentiallyreduced battery life, reduced storage capacity for medical preparationsto be delivered and other potentially adverse effects. Accordingly, aneed exists for a way to configure a medical device so that it canmaintain fully beneficial operation while facilitating implantationthrough a reduced size incision. A solution to this problem wouldbeneficially also be at least as resistant to “Twiddlers Syndrome” asprior art medical devices.

SUMMARY OF THE INVENTION

With this invention an implantable medical device is provided which canbe implanted through a relatively small incision and yet maintain fullstability at the implantation site. The medical device includes ahousing which has an elongate form. This elongate form is defined by along axis extending between front and rear ends thereof and a lateralaxis extending between lateral sides of the housing. The long axis islonger than the lateral axis, and typically at least about twice as longas the lateral axis.

Equipment within the housing for the medical device is configured asappropriate to fit within this elongate housing, rather than in priorart housings which are generally either circular in form orrectangular/square in form. With such an elongate form, it is onlynecessary that an incision be provided large enough to allow the passageof the lateral cross-section of the housing, perpendicular to the longaxis, to pass through the incision. For instance, if the housing is twoinches long, one-half inch wide and one-half inch high, an incision ofone-half inch in length (or slightly greater) is sufficient to allowpassage of the housing of the medical device therethrough.

Furthermore, a stabilizing element is associated with the housing. Thisstabilizing element has both an elongate narrow form and a deployed widelateral form to enhance stability of the housing and hence the entiremedical device at the implantation site. This stabilizing element can bein the form of one or more wings pivotably attached to the housing.These wings have an elongate form between ends thereof with these endsaligned with the long axis of the housing during implantation. After thehousing and wing have arrived at the implantation site, the wing can berotated so that the ends thereof extend laterally away from lateralsides of the housing to stabilize the medical device. Once sostabilized, the medical device has just as much (or more) stability atthe implantation site as it would have if it was not provided with thisparticularly elongate form. Hence, a small incision has been facilitatedwithout any adverse impact on functionality of the medical device.

In another form, this stabilizing element is in the form of a separateloop and the housing is provided with a cavity therein with a rearopening and at least one (and preferably two) lateral side opening. Theloop is routed through the rear opening and then is caused to expandwithin the cavity to expand out the at least one side opening to provideenhanced stability to the medical device. The loop can be bent withinthe cavity to extend laterally out of the side openings to stabilize thehousing. Alternatively, the loop can be formed of a resilient materialwhich is initially restrained into an elongate form aligned with thelong axis of the housing, but which springs to a natural original formafter passing into the cavity where portions of the loop extend out thelateral side openings of the cavity, to stabilize the housing after theloop has been inserted entirely within the cavity.

OBJECTS OF THE INVENTION

Accordingly, a primary object of the present invention is to provide amedical device which can pass through a reduced size incision whilemaintaining stability at an implantation site subcutaneously within thebody of a patient.

Another object of the present invention is to provide a medical devicewhich can be implanted into a subcutaneous implantation site within thebody of a patient.

Another object of the present invention is to provide a method forimplanting a medical device and stabilizing the medical device onceimplanted.

Another object of the present invention is to provide a subcutaneousimplantable medical device which has a small cross-section forimplantation through a small incision which maintains high stabilityonce implanted.

Another object of the present invention is to provide a medical devicewhich can morph between a smaller profile implantation form and a largerprofile static implanted form after being implanted at an implantationsite.

Another object of the present invention is to provide a pacemaker whichcan be implanted through a small incision and still maintain stabilityonce implanted.

Another object of the present invention is to provide a medical devicewhich can be stabilized after implantation with the stabilizationprocess easily and reliably performed by a medical professional.

Other further objects of the present invention will become apparent froma careful reading of the included drawing figures, the claims anddetailed description of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a bottom plan view of an implantable medical device shownbefore rotation of a wing thereof to stabilize the medical device.

FIG. 2 is a bottom plan view similar to that which is shown in FIG. 1but after rotation of the stabilizing element in the form of a wing tostabilize the medical device.

FIG. 3 is a bottom plan view of an implantable medical device having acavity and a loop which can pass into the cavity and expand within thecavity to stabilize the housing.

FIG. 4 is an end elevation view of that which is shown in FIG. 3.

FIG. 5 is a side elevation view of that which is shown in FIG. 3.

FIG. 6 is a bottom plan view of that which is shown in FIG. 3 but with astabilizing element in the form of a loop delivered through a cannula toutilize the stabilizing element in the form of a loop that is biasedtoward a deployed position but retrained in a narrow configurationbefore insertion into the cavity of the housing.

FIG. 7 is a bottom plan view similar to that which is shown in FIG. 6but after positioning of the stabilizing element from the cannula intothe cavity.

FIG. 8 is a bottom plan view of an alternative embodiment medical deviceand associated cannula with the medical device featuring a pair ofrotating wings pivotably attached thereto and a spreader rod for use inspreading the pair of wings opposite each other for conversion of themedical device from an implantation form to a stabilized form.

FIG. 9 is a bottom plan view similar to that which is shown in FIG. 8but after advancing the spreader rod and rotating the wings to the finalstabilized configuration.

DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring to the drawings, wherein like reference numerals representlike parts throughout the various drawing figures, reference numeral 10(FIGS. 1 and 2) is directed to a pacemaker as one form of medical deviceillustrative of the enhanced stability implantable medical device ofthis invention. In addition to pacemakers 10, infusion pumps, ports andother medical devices could similarly be provided and utilize the samestabilization element and housing 20 as the pacemaker 10. The pacemaker10 has an elongate form to allow it to be implanted through a smallincision. A shape of the housing 20 of the pacemaker 10 is modifiedafter arriving at the subcutaneous implantation site to enhancestability of the pacemaker 10 or other medical device implant. Twoalternative embodiments are also disclosed herein including a firstalternative pacemaker 110 (FIGS. 3-7) and a second alternative pacemaker210 (FIGS. 8 and 9).

In essence, and with particular reference to FIGS. 1 and 2, basicdetails of the pacemaker 10 of the preferred embodiment are described.The pacemaker 10 includes at least a portion of medical devicecomponents thereof within a housing 20. The housing 20 is generallyelongate in form aligned with a long axis. An axle 30 extendsperpendicularly from this long axis and between sides of the housing 20.A wing 40 is pivotably attached to the housing 20, such as through theaxle 30. The wing 40 can rotate between an initial position where it isaligned with the long axis of the housing 20 and a deployed form (arrowA), where it is rotated to enhance a width of the housing 20 and enhancea stability of the pacemaker 10. Electrical leads 50 are shown extendingfrom the pacemaker 10 to output an appropriate electrical signal forheartbeat control. An outlet tube 60 is alternatively shown should thepacemaker 10 be replaced with some other medical device which delivers afluid preparation into the body of the patient.

More specifically, and with continuing reference to FIGS. 1 and 2,specific details of the housing 20 are described according to thispreferred embodiment. The housing 20 is an enclosure for at leastportions of the pacemaker 10 or other medical device. Contents of thehousing 20 can include a power supply, such as a battery, andappropriate control electronics for delivering an electrical signal toelectrical leads 50 when specified to the heart of the patient. If aninfusion pump type medical device is substituted, the housing 20 couldcontain a reservoir, pump elements, valves and other components typicalof infusion pumps. This housing 20 is preferably substantiallycompletely enclosed and preferably rigid in form.

The housing 20 generally includes a perimeter 22 including opposite ends24 and opposite sides 26 extending between the ends 24. The housing 20also includes a bottom 25 spaced from a top. The housing 20 in thispreferred embodiment generally has a constant cross-section size betweenthe bottom 25 and the top and preferably a thickness between the bottom25 and the top that is similar to a width between the sides 26. The ends24 and sides 26 are preferably substantially planar, but can be somewhatrounded if desired.

Importantly, the housing 20 exhibits an elongate form so that the ends24 are spaced further from each other than a spacing between the sides26 and a spacing between the bottom 25 and the top. Most preferably,this amount of elongation is such that a length of the housing 20 alonga long axis between the ends 24 is at least about twice as great as alength of a lateral axis extending between the sides 26. The housing 20can exhibit a greater degree of elongation with the length between theends 24 more than twice as great as a width between the sides 26, orslightly less than this preferred amount and still benefit from theconcept of this invention.

The pacemaker 10 is shown with an axle 30 extending down from the bottom25 of the housing 20 perpendicular to the long axis and perpendicular tothe lateral axis of the housing 20. While this axle 30 is not strictlyrequired, it is beneficially provided to allow for pivotable attachmentof the wing 40 to the bottom 25 of the housing 20. As an alternative tothe separate axle 30, an axle-like structure can be formed into thehousing 20 or the wing 40 to cooperate with a hole in the housing 20 orthe wing 40. When the axle 30 is utilized, it fits within an appropriatecylindrical hole extending into the bottom 25 of the housing 20 andthrough the wing 40. This axle 30 is preferably cylindrical in form andhas a length merely sufficient to extend a distance similar to athickness of the wing 40.

With continuing reference to FIGS. 1 and 2, details of the wing 40 aredescribed according to this preferred embodiment. The wing 40 ispreferably a rigid structure pivotably attached to the housing 20through the axle 30. This wing 40 preferably has a contour similar tothat of the housing 20 so that the wing 40 also exhibits an elongateform. A hole 42 is provided for mounting the wing 40 to the axle 30. Thewing 40 extends between opposing ends 44 with sides 46 extending betweenthe ends 44. The sides 46 are opposite each other and define a width ofthe wing 40 with a length of the wing 40 defined by a distance betweenthe ends 44. A thickness of the wing 40 is defined by a distance betweena bottom 45 of the wing 40 and a top of the wing 40. The top of the wing40 is located adjacent the bottom 25 of the housing 20.

Most preferably, the wing 40 has a perimeter size slightly less than theperimeter 22 of the housing 20. As an alternative, the wing 40 could beprecisely the same perimeter size as the housing 20 or could be slightlylarger than a perimeter 22 of the housing 20 and still functionadequately according to this invention. Importantly, the wing 40 ispreferably also elongate in form with a length about twice (or more)that of a width thereof.

The wing 40 is adapted to rotate relative to the housing 20 (along arrowA of FIGS. 1 and 2). This rotation allows the wing 40 to change from animplantation configuration to a deployed configuration for the housing20, so that the housing 20 goes from having an elongate low profileform, such as while being passed through a small incision, to a largestable platform once implanted. This minimizes the possibility of“Twiddler's Syndrome” or other undesirable movement of the pacemaker 10or other medical device once implanted.

Electrical leads 50 or outlet tubes 60 preferably extend from one of theends 24 of the housing 20 or some other portion of the housing 20. Tokeep the wing 40 in its deployed position, it is conceivable that thebottom 25 of the housing 20 and the top of the wing 40 could beconfigured so that they include appropriate detent structures so thatthe wing 40 snaps into a final deployed position once rotated relativeto the housing 20. Alternatively, holes can be formed in the housing 20and the wing 40 which can receive sutures to tie the wing 40 in its openposition relative to the housing 20.

Should the pacemaker 10 or other medical device require removal, thewing 40 can merely be rotated back to its implantation position byovercoming forces associated with the detents in the wing 40 and thehousing 20, or by severing sutures to allow the wing 40 to freely rotateback to its implantation position with a long axis of the wing 40aligned with a long axis of the housing 20. Whenever such implantationor removal occurs, a relatively small incision is required to passthrough the skin and yet a stable medical device is still provided.

While the wing 40 is shown as a preferred form of stabilizing element,other forms of stabilizing elements could also be utilized includingspring loaded stabilizing elements which automatically deploy afterpassing through the skin or reaching the incision site. Also, the wing40 could be in the form of a pair of wings (FIGS. 8 and 9) or could be astructure having a form generally that of a “T” or “V” which eitherrotates relative to the housing 20 or is spring loaded to deploy arms toenhance a width of the medical device after complete implantation.

The wing 40 can be rotated after the medical device has reached theimplantation site or immediately after passing through an incision inthe skin. Such rotation can occur manually, such as through use of anappropriate probe or manipulation with the fingers. Most preferably,such rotation is achieved through use of a spring that biases the wing40 to its deployed position extending laterally from the housing 20 longaxis. Such a spring can be a torsion spring adjacent the axle 30 andcontained within a recess in the wing 40 adjacent the axle 30, and/or arecess in the bottom of the housing 20 adjacent the axle 30. The springcould be formed of a biocompatible metal such as titanium (or alloysthereof) or made of a biocompatible plastic or other other non-metalmaterial. The spring could also be a linear compression spring or otherlinear force applying spring located further from the axle 30 andinterposed between the wing 40 and the housing 20. With such a spring,the wing 40 is both advanced to the deployed configuration and held inthe deployed configuration after rotation. Further support in thedeployed position can be provided by detents or suturing also.

With particular reference to FIGS. 3-7, details of the first alternativepacemaker 110 are described. The pacemaker 110 includes a housing 120with a general elongate form similar to that of the housing 20. Thus,the housing 120 includes a front end 122 opposite a rear end 124 withsides 126 extending between the front end 122 and rear end 124. Athickness of the housing 120 is defined as a distance between the bottom125 and top 128.

Uniquely, the housing 120 includes a cavity 130 therein. Preferably,this cavity 130 is closer to the bottom 125 than to the top 128 and hasa planar form within a plane perpendicular to a vertical axis andaligned with both a long axis and a lateral axis for the housing 120. Along axis is defined as an axis extending from the front end 122 to therear end 124 and the lateral axis is defined as an axis extendingbetween the sides 126. The cavity 130 includes a roof 132 which isplanar in form and spaced a constant distance away from a floor 134. Anabutment wall 135 defines a wall extending from the roof 132 to thefloor 134 on a side of the cavity 130 adjacent the front end 122 of thehousing 120. The cavity 130 also includes side openings 136 extendingout sides 126 of the housing 120 and a rear opening 138 extending out ofthe rear end 124 of the housing 120.

A loop 140 is provided as a preferred form of stabilizing element whichcan reside within the cavity 130 and extend laterally out of at leastone of the side openings 136 and preferably both of the side openings136 to stabilize the housing 120 after implantation. The loop 140 inthis preferred form shown includes four legs 142 joined together by afront joint 146, side joints 144 and a rear joint 148. The front joint146 is located adjacent the abutment wall 135. The rear joint 148 isadjacent the rear opening 134. The side joints 144 are adjacent the sideopenings 136. The loop 140 is sized so that the side joints 144 extendout of the side openings 136 and enhance an effective width andfootprint of the housing 120 of the first alternative pacemaker 110. Aninterface port 150 extends from the housing 120 which can be in the formof electric leads or a fluid tube depending on the type of medicaldevice provided, such as the pacemaker 110.

While a continuous loop 140 is shown, other stabilizing elements couldbe provided of similar form but not a complete loop. For instance, anyone of the joints might be omitted so that adjacent legs 142 end at freeends, and such a modified loop would still function somewhateffectively.

The loop 140 can be deployed a variety of different ways relative to thecavity 130 of the housing 120. In one embodiment the loop 140 can beprovided within the cavity 130 during implantation. The loop 140 can besufficiently flexible that as the pacemaker 110 is advanced through anincision, the side joints 144 are merely flexed towards each other asthey pass through the incision. The loop 140 would be formed of aresilient material so that the side joints 144 would spring to a naturaloriginal position (along arrow C of FIGS. 3 and 7) once reaching theimplantation site.

Alternatively, the loop 140 could be formed of a plastically deformablematerial, such as a surgical stainless steel with thin cross-sectionlegs 142 and initially reside within the cavity 130, but passing out ofthe rear opening 138 somewhat and not passing out of the side openings136. After reaching the implantation site, the rear joint 148 would beadvanced toward the front joint 146 and the loop 140 would be caused tobend so that the side joints 144 would bend away from each other and outof the side openings 136.

As another alternative, the loop 140 could be formed as bendablematerial but be advanced later, such as through a cannula (along arrow Bof FIGS. 3, 6 and 7), until the front joint 146 abuts the abutment wall135 and then with further advancing of the loop 140 is caused to bend sothe side joints 144 extend out the side openings 136 of the cavity 130.Also, the loop 140 could be formed of a resilient material, such asnickel titanium and still advance (arrow B) through a catheter/cannula160 that would initially restrain the loop 140 to have an elongate form(FIG. 6) and after advancing into the cavity 130 would be allowed toattain its natural original form (arrow C) deployed into a generallydiamond shape (FIG. 7) to provide the stable enhanced width footprintfor the pacemaker 110 or other medical device, once at the implantationsite.

With particular reference to FIGS. 8 and 9, details of a secondalternative pacemaker 210 or other medical device are disclosed. Thissecond alternative pacemaker 210 has a housing 220 similar to thehousing 20 of the preferred embodiment (FIGS. 1 and 2). Thus, thehousing 220 includes a perimeter 222 defined by ends 224 at oppositeends of a long axis and sides 226 extending between the ends 224 anddefining a lateral axis extending therebetween. The housing 220 alsoincludes a top opposite a bottom 225 defining a thickness of the housing220. Electric leads 280 or other output extends from the housing 220. Anaxle 230 extends from the bottom 225 of the housing 220 in a mostpreferred form of this second alternative pacemaker or other medicaldevice.

Uniquely, a pair of wings 240, 250 are pivotably attached to the axle230 of the housing 220. In particular, these wings 240, 250 include atop wing 240 and a bottom wing 250. The top wing 240 is closer to thebottom 225 of the housing 220 and includes a hub 242 adjacent the axle230 with a hole therein that allows the top wing 240 to be mounted tothe axle 230. Arms 244 extend in opposite directions away from the hub242 to tips 246. A recess 245 is provided adjacent the hub 242 intowhich the bottom wing 250 can partially reside so that the top wing 240and bottom wing 250 can remain within a substantially common plane witheach other both before and after rotation thereof. Preferably, at leastone of the tips 246 of the top wing 240 includes a bevel 248 thereon ona portion of the top wing 240 which extends most rearwardly on the topwing 240.

The bottom wing 250 includes a hub 252 adapted to be mounted on the axle230 and adapted to reside within the recess 245 in the top wing 240. Thebottom wing 250 is most distant from the bottom 225 of the housing 220.Arms 254 extend in opposite directions away from the hub 252 to tips256. Preferably, at least one of the tips 256 includes a bevel 258thereon on a portion of one of the arms 254 which extends mostrearwardly. This bevel 258 preferably at least partially faces the bevel248 of the top wing 240.

The wings 240, 250 are each adapted to rotate relative to each other andrelative to the housing 220 (arrows E and F). Initially, the wings 240,250 reside substantially within a perimeter 222 of the housing 220.After rotation (along arrows E and F) the wings 240, 250 extend outsidethis perimeter 222 of the housing 220 to enhance the stability of thepacemaker 210 or other alternative medical device.

Preferably, a cannula 260 can be placed adjacent the pacemaker 210 and aspreader rod 270 can be advanced through the cannula 260 and pressedbetween the bottom wing 250 and top wing 240. The spreader rod 270 canpress against the bevel 248 and bevel 258 to cause simultaneous rotationof the top wing 240 and bottom wing 250 in opposite directions relativeto each other and relative to the housing 220. Such rotation preferablyoccurs for at least 45° so that the wings 240, 250 form an “X.” A ratherdesirable stabilized form would involve rotation of 60° so that thewings 240, 250 and ends 224 of the housing 220 would define sixperipheral ends for the overall final implanted pacemaker 210 or otherimplanted medical device. Advancement of the spreader rod 270 alongarrow D (FIGS. 8 and 9) allows for such rotation (along arrows E and F)for rotation of the wings 240, 250 from an implantation position to adeployed position.

The medical device 210 can have the pair of wings advanced and held inthe deployed position by action of a spring, similar to that describedin conjunction with the embodiment of FIGS. 1 and 2 above. With twowings, the spring can act between the springs or two springs can beprovided, each acting between the housing and one of the wings.

This disclosure is provided to reveal a preferred embodiment of theinvention and a best mode for practicing the invention. Having thusdescribed the invention in this way, it should be apparent that variousdifferent modifications can be made to the preferred embodiment withoutdeparting from the scope and spirit of this invention disclosure. Whenstructures are identified as a means to perform a function, theidentification is intended to include all structures which can performthe function specified. When structures of this invention are identifiedas being coupled together, such language should be interpreted broadlyto include the structures being coupled directly together or coupledtogether through intervening structures. Such coupling could bepermanent or temporary and either in a rigid fashion or in a fashionwhich allows pivoting, sliding or other relative motion while stillproviding some form of attachment, unless specifically restricted.

1: A method for minimally invasive implantation of a subcutaneousmedical device, the method including the steps of: configuring themedical device to be at least partially contained within a housinghaving an elongate form with a long axis between ends greater than alateral axis non-parallel with the long axis; making an incision largeenough to pass the housing through the incision along the long axis;passing the housing through the incision to a subcutaneous implantationsite; and manipulating a stabilizing element coupled to the housing toenhance a lateral width of the housing, such that the stabilizingelement resists rotation of the housing about the long axis. 2: Themethod of claim 1 including the further steps of: configuring thestabilizing element as a rotating wing pivotably attached to thehousing; and said manipulating step including the step of rotating thestabilizing element from a first position aligned with the long axis toa second position extending laterally a distance greater than a width ofthe housing. 3: The method of claim 2 including the further step ofconfiguring the rotating wing to have a length greater than a width ofthe housing so that ends of the rotating wing extend laterally fromsides of the housing upon rotation of the rotating wing at least 45°from initially aligned with the long axis. 4: The method of claim 2wherein said manipulating step includes the step of manipulating a pairof the stabilizing elements in the form of a pair of rotating wings inopposite directions relative to the housing. 5: The method of claim 4including the further step of advancing a spreader rod toward thehousing and between the two wings to cause rotation of the two wings inopposite directions away from each other and relative to the housing. 6:The method of claim 1 including the further steps of: configuring thehousing to include a cavity therein with a rear opening and at least oneside opening; and configuring the stabilizing element to be in the formof an expandable element which can pass through the rear opening andexpand laterally out of said at least one side opening. 7: The method ofclaim 6 including the further steps of: configuring the cavity toinclude at least two side openings opposite each other; and extendingsaid expandable element laterally out of both side openingssimultaneously. 8: The method of claim 7 including the further steps ofconfiguring the expandable element as a loop. 9: The method of claim 8including the further steps of configuring the expandable element toinclude four legs joined together by four joints including two sidejoints which extend away from each other and out of the side openingswhen a rear joint of the loop is moved toward a front joint of the loop.10: A method for reconfiguring a subcutaneous medical device, the methodincluding the steps of: identifying a subcutaneous medical device atleast partially contained within a housing and having an elongate formbetween a front end spaced from a rear end by a longest dimension andextending along a long axis, the housing having lateral sides spacedfrom each other by a lateral width that is less than the longestdimension; and manipulating a stabilizing element to be coupled to thehousing and enhance the lateral width of the housing, such that thestabilizing element resists rotation of the housing about the long axisafter the stabilizing element is coupled to the housing. 11: The methodof claim 10 wherein said manipulating step includes the step ofdeforming the stabilizing element from a first configuration that isnarrower than the width of the housing between the lateral sides, into asecond configuration that is wider than the width of the housing betweenthe lateral sides. 12: The method of claim 11 including the further stepof extending the stabilizing element laterally in opposite directionspast each of the lateral sides of the housing. 13: The method of claim12 including the further steps of identifying a cavity in the housingwith lateral side openings and a rear opening, and inserting thestabilizing element into the rear opening and causing the stabilizingelement to extend laterally out of the side openings in the cavity ofthe housing. 14: The method of claim 13 including the step ofconfiguring the stabilizing element to maintain plastic deformationafter extending out of the side openings in the cavity. 15: The methodof claim 14 including the further step of identifying the stabilizingelement having a resilient character and with a bias toward a widthsufficient to extend out of the openings in the cavity of the housingunless forces are applied to the stabilizing element to elasticallycompress the stabilizing element to a width less than the width of thehousing. 16: The method of claim 10 including the further step ofcoupling the stabilizing element to the housing with the stabilizingelement having a longest dimension greater than the lateral width of thehousing, with the stabilizing element coupled in an orientation whichenhances an overall lateral width of the housing when the stabilizingelement is coupled thereto. 17: A method for stabilizing a subcutaneousmedical device, the method including the steps of: identifying asubcutaneous medical device at least partially contained within ahousing and having an elongate form between a front end spaced from arear end by a longest dimension and extending along a long axis, thehousing having lateral sides spaced from each other by a lateral widthless than the longest dimension; and manipulating a stabilizing elementcoupled to the housing, to move the stabilizing element from a firstorientation with the stabilizing element inboard of the lateral sides ofthe housing to a second orientation with at least one tip of thestabilizing element extending past at least one lateral side of thehousing, such that the stabilizing element resists rotation of thehousing about the long axis. 18: The method of claim 17 wherein saidmanipulating step includes pivoting an elongate wing that defines aportion of the stabilizing element about an axle extending perpendicularto the long axis, the wing including at least one tip spaced from theaxle sufficient to cause the tip to extend past at least one lateralside of the housing when the pivoting wing is pivoted away from anorientation parallel with the housing long axis. 19: The method of claim18 including the further step of configuring the stabilizing element toinclude a pair of wings each attached about a common axle perpendicularto the long axis of the housing, the wings each pivoting from a firstposition corresponding with a first orientation and substantially withinan outline of the housing and a second position corresponding with thesecond orientation with tips of the wings extending from the lateralsides of the housing, such that the stabilizing elements resist rotationof the housing about the long axis. 20: The method of claim 19 includingthe further step of providing a push rod which can push between adjacentends of the two wings to spread the adjacent ends of the two wings awayfrom each other and cause the two wings to rotate from the firstposition to the second position.